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Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118039
Recruitment Status : Unknown
Verified September 2012 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 6, 2010
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to see how well it works in treating patients with locally recurrent, locally advanced, unresectable, or metastatic urinary tract cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Drug: sunitinib malate Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • To determine the time to disease progression (defined as the time from diagnosis of metastatic urothelial carcinoma until first confirmed progression of the disease) in patients with locally recurrent, locally advanced, unresectable, or metastatic urothelial cancer treated with sunitinib malate and ineligible for cisplatin-based chemotherapy.
  • To determine the safety of this drug in these patients.


  • To determine the progression-free survival of patients treated with this drug.
  • To determine the overall response rate in patients treated with this drug.
  • To determine the overall survival of patients treated with this drug.
  • To determine the time to treatment failure in patients treated with this drug.
  • To determine the pharmacodynamic profile of this drug in pre- and post-treatment serum and tumor tissue (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis [H/E]) at week 6, and if possible, at time of progression.
  • To determine the quality of life of patients treated with this drug using the QLQ-C30 version 3 questionnaire.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaire (EORTC QLQ-C30) before, during, and at the end of study treatment.

Serum and tumor tissue samples are collected at baseline and after study treatment for pharmacodynamic studies. Samples are analyzed for markers (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis [H/E]) via immunohistochemistry.

After completion of study treatment, patients are followed for 28 days and then every 2 months for up to 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy
Study Start Date : July 2006
Estimated Primary Completion Date : December 2010

Primary Outcome Measures :
  1. Time to disease progression
  2. Safety

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall response rate
  3. Overall survival
  4. Time to treatment failure
  5. Pharmacodynamic profile
  6. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed transitional cell carcinoma of the urinary tract meeting ≥ 1 of the following criteria:

    • Unresectable, locally recurrent disease

      • Locally recurrent disease must not be amenable to resection or radiotherapy with curative intent
    • Locally advanced or metastatic disease

      • No prior chemotherapy for advanced disease
  • Ineligible (unfit) for cisplatin-based chemotherapy due to creatinine clearance < 60 mL/min but > 30 mL/min
  • Measurable or nonmeasurable disease according to RECIST criteria

    • Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy


  • See Disease Characteristics
  • ECOG performance status 0-1
  • Life expectancy > 12 weeks
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
  • Serum albumin ≥ 3.0 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study therapy
  • No diagnosis of a second malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • None of the following within the past 12 months:

    • Myocardial infarction
    • Severe/unstable angina
    • Coronary/peripheral artery bypass graft
    • Congestive heart failure
    • Cerebrovascular accident, including transient ischemic attack
    • Pulmonary embolus
  • No ongoing cardiac dysrhythmias (NCI CTCAE grade ≥ 2), atrial fibrillation of any grade, or QTc interval > 450 msec (males) or > 470 msec (females)
  • No hypertension that cannot be controlled by medications (> 150/100 mm Hg despite optimal medical therapy)
  • No known HIV infection
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which would make the patient inappropriate for entry into this study


  • See Disease Characteristics
  • Recovered from all acute toxic effects of prior therapy or surgical procedures to grade ≤ 1 (except alopecia)
  • At least 3 weeks since prior major surgery, radiotherapy, or systemic therapy (except palliative radiotherapy to non-target metastatic lesions)
  • Not enrolled in a dialysis program or anticipating a need for dialysis
  • No prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract
  • No prior treatment on another sunitinib malate clinical trial
  • No prior tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors
  • No prior high-dose chemotherapy requiring hematopoietic stem cell rescue
  • No prior radiotherapy to > 25% of the bone marrow
  • No concurrent treatment on another clinical trial
  • No concurrent treatment with therapeutic doses of acenocoumarol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118039

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Hospital Del Mar Recruiting
Barcelona, Spain, 08003
Contact: Contact Person    34-39-3248-3861   
Hospital de la Santa Cruz i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Contact Person    34-93-553-7118   
Hospital Universitario San Carlos Recruiting
Madrid, Spain, 28040
Contact: Contact Person    34-91-330-3000, Ext. 7935   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Contact Person    34-91-469-2313   
Sponsors and Collaborators
Hospital del Mar
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OverallOfficial: Joaquim Bellmunt, MD, PhD Hospital del Mar

Layout table for additonal information Identifier: NCT01118039     History of Changes
Other Study ID Numbers: HDM-SU-011248
CDR0000671673 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: September 2012

Keywords provided by National Cancer Institute (NCI):
localized transitional cell cancer of the renal pelvis and ureter
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
transitional cell carcinoma of the bladder
distal urethral cancer
proximal urethral cancer
recurrent urethral cancer
recurrent bladder cancer
stage IV bladder cancer
stage III bladder cancer
urethral cancer associated with invasive bladder cancer
stage III urethral cancer
stage IV urethral cancer

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action